What is NDC 58468-0070?

58468-0070 is the product NDC for Aldurazyme (laronidase), Laronidase 2.9 mg/5mL injection, solution, concentrate, listed with the FDA by Genzyme Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.

Genzyme Corporation, NDC labeler code 58468. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Aldurazyme?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Aldurazyme NDC 58468-0070 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58468-0070Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58468-0070Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
58468-0070-1	58468007001	5 mL in 1 VIAL, GLASS (58468-0070-1)Marketed from Apr 30, 2003

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Aldurazyme
Generic name (nonproprietary): laronidase
Active ingredients: Laronidase — 2.9 mg/5mL
Dosage form: Injection, Solution, Concentrate
Route: Intravenous
Labeler: Genzyme CorporationNDC labeler code 58468
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125058
Marketing start: Apr 30, 2003
Listing expires: Dec 31, 2027
Other FDA classes: alpha-Glucosidases (Chemical structure)
Identifiers: Product ID 58468-0070_c37ec1bf-5497-45ca-a204-915b91bff0f6SPL ID c37ec1bf-5497-45ca-a204-915b91bff0f6
Pharmacologic class: Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N458468007001 followed by a unit qualifier and the quantity

Package 58468-0070-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

The FDA listing for this product does not reference a label (SPL) set.

About NDC 58468-0070

What is NDC 58468-0070?: 58468-0070 is the product NDC for Aldurazyme (laronidase), Laronidase 2.9 mg/5mL injection, solution, concentrate, listed with the FDA by Genzyme Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Aldurazyme (Laronidase).
What is the active ingredient?: Laronidase.
Who is the labeler?: Genzyme Corporation, NDC labeler code 58468. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Aldurazyme?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Aldurazyme (Laronidase) NDC 58468-0070